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Clinical trial

DiaSurg 2 trial: surgical vs. medical treatment for T2DM

Study will report outcomes 8 years post-treatment

The recently announced DiaSurg 2 randomised clinical trial will assess which treatment -  Roux-en-Y gastric bypass surgery or medical treatment  - is the most efficient method for type 2 diabetes mellitus glycaemic control in terms of preventing long-term complications and mortality in non-severely obese patients (BMI 26-35).

The DiaSurg 2 trial is a multi-centre, open randomised controlled trial comparing RYGB including standardised medical treatment if needed to exclusive standardised medical treatment of T2DM (control group).

Dr Markus W Büchler, Heidelberg, will led the study

The primary endpoint is a composite time-to-event endpoint (cardiovascular death, myocardial infarction, coronary bypass, percutaneous coronary intervention, non-fatal stroke, amputation, surgery for peripheral atherosclerotic artery disease), with a follow-up period of eight years.  

Insulin-dependent T2DM patients aged between 30 and 65 years will be included and randomly assigned to one of the two groups. Statistical analysis will be based on Cox proportional hazards regression for the intention-to-treat population. Assuming a loss to follow-up rate of 20%, 200 patients will be randomly allocated to the comparison groups (total sample size of n=400 is sufficient to ensure 80% power in a two-tailed significance test at alpha = 5%).

Secondary endpoints include the time to death from any cause and the time to each component of the primary endpoint. In addition, laboratory parameters for T2DM (HbA1c, C-peptide and glucagon stimulated C-peptide, fasting glucose, fasting insulin, oral glucose tolerance test), regular laboratory parameters (i.e. lipid profiles, serum creatinine, creatinin clearance) as well as vitamins and micronutrients (vitamin B6, B12, folate acid and iron status) will also be assessed.

Additional parameters will include the amount of medication (insulin dosage, metformin, antihypertensive therapy, etc.), the assessment of nephropathy (urine albumin excretion 24-hours urine sample), retinopathy (according to the EURODIAB six-level grading scale), peripheral neuropathy (assessed by biothesiometry of the big toe in both feet and questionnaire) and quality of life. Data assessment will be after randomization and then three, six,12 months afterwards and then annually.

The German trial, led by Dr Markus W Büchler, University Medical Center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Heidelberg, began enrolment in January 2013 and is also recruiting patients at the University Medical Center Medizinische Klinik, Abteilung Innere Medizin I: Endokrinologie und Klinische Chemie, Heidelberg, Medical Center Klinik für Allgemein- und Viszeralchirurgie, Sachsenhausen, and Medical Center  Klinik für Allgemein- und Viszeralchirurgie, Karlsruhe.

The trial protocol has been registered in the German Clinical Trials Register DRKS00004550. Additional details can be found here.

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